[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.65]

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                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
            Subpart D--Requirements for Specific Animal Drugs
 
Sec.  500.65  Epinephrine injection 1:1,000 in 10-milliliter containers for emergency treatment of anaphylactoid shock in cattle, horses, sheep, and swine.


    (a) Anaphylactoid reactions in cattle, horses, sheep, and swine 
occur occasionally from the injection of antibiotics, bacterins, and 
vaccines. Adequate directions for use of these antibiotics, bacterins, 
and vaccines can generally be written for use by the laity and thus are 
available to livestock producers. Epinephrine injection is effective for 
the treatment of anaphylactoid reactions in animals and would be of 
value in saving lives of animals if it were readily available at the 
time of administration of the causative agents. In connection with this 
problem the Food and Drug Administration has obtained the views of the 
Advisory Committee on Veterinary Medicine, and other experts, and has 
concluded that adequate directions for over-the-counter sale of 
epinephrine injection 1:1,000 can be prepared.
    (b) In view of the above, the Commissioner of Food and Drugs has 
concluded that it is in the public interest to make epinephrine 
injection 1:1,000 available for sale without a prescription provided 
that it is packaged in vials not exceeding 10 milliliters and its label 
bears, in addition to other required information, the following 
statements in a prominent and conspicuous manner: ``For emergency use 
only in treating

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anaphylactoid shock. Usual Dosage: Cattle, horses, sheep, and swine--1 
cubic centimeter per 100 pounds of body weight. Inject subcutaneously''.
    (c) The labeling must also bear a description of the symptoms of 
anaphylactoid shock including glassy eyes, increased salivation, 
grinding of the teeth, rapid breathing, muscular tremors, staggering 
gait, and collapse with death following. These symptoms may appear 
shortly after injection of a bacterin, vaccine, or antibiotic.